Secretin Infusion for Pain Due to Chronic Pancreatitis



Status:Completed
Conditions:Chronic Pain, Gastrointestinal
Therapuetic Areas:Gastroenterology, Musculoskeletal
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:December 2010
End Date:April 2012

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- To determine if intravenous secretin administration in escalating doses three times
daily for three days will improve the pain from CP at the time of infusion, after each
infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.

- To validate the safety of intravenous secretin administration at the dosage indicated
in this study.

12 patients will be enrolled in this study. Patients will be only those treated at
Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made
by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients
must be taking prescribed opioid analgesics for the specific treatment of CP at the time of
study enrollment. Only patients between the ages of 18-70 and capable of providing informed
consent will be considered eligible for the study.

Inclusion Criteria:

1. Male or female, between the ages of 18-70 years old.

2. Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP
and/or pancreatic function tests.

3. If female, and not more than 1 year post-menopausal or surgically sterile, must use
medically acceptable form of contraception or abstain from sexual activity during the
study. Acceptable methods of birth control are: intrauterine device, implantable
progesterone device, progesterone intramuscular injection, oral contraceptive
(started at least one month prior to Screening Visit 1 and continuing for the
duration of the trial), contraceptive patch, condoms with spermicide or abstinence.

4. If a female of reproductive potential, receive counseling on pregnancy protection and
effective contraception within 30 days prior to dosing with secretin.

5. Negative serum pregnancy within 72 hours of secretin administration.

6. Use of opioid analgesics for chronic pain from CP.

7. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Male or female <18 or >70 years of age.

2. Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days
of study enrollment.

3. Exhibiting signs and/or symptoms of an episode of acute pancreatitis.

4. Severe cardiac disease (stable or unstable angina, congestive heart failure,
uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).

5. Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).

6. Severe renal disease (history of acute or chronic renal failure, dialysis dependent,
baseline creatinine >2.0 mg/dL).

7. Previous adverse drug event to intravenous secretin.

8. Ongoing illicit drug use or abuse.

9. Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine
and/or 1 oz liquor /day.

10. Acute pancreatitis as defined by the Atlanta Classification definition (refer to
Table 1) within the previous two months or symptoms consistent with ongoing acute
pancreatitis.

11. Prior pancreatic surgery.

12. Pregnant women, nursing mothers, or women of childbearing potential not employing
appropriate contraception.

13. Use of medication that can potentially cause pancreatitis, such as metronidazole,
tetracycline, sulfonamides within 30 days prior to Visit 1.

14. Any medical condition which, in the judgment of the investigator, renders
participation in this study medically inadvisable.

15. Participation in an investigational clinical study for a drug or medical device
within 30 days prior to Visit 1.

16. Unwilling or unable to give written, informed consent.
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Lebanon, New Hampshire 03756
 (603) 650-5000
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